Longitudinal Endpoint Assessment of Disease Burden in HD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Huntington Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
LEAD-HD is intended to collect and analyze self-reported health information from individuals with Huntington Disease (HD) or prodromal HD participating in a 24-month longitudinal natural history study using remote technologies.
Detailed description
The LEAD-HD study will be offered via HSG's online observational research platform called myHDstory®. This direct to patient study will collect and analyze self-reported health information from individuals with Huntington Disease (HD) or prodromal HD in a 24-month longitudinal natural history study that participants complete at any time and with their own electronic device.
Primary outcome measures
- PRO natural history [Time frame: December 2026]
- Demographic characteristics [Time frame: December 2026]
- Assess the ability to consent and enroll [Time frame: December 2026]
Eligibility criteria
Inclusion criteria
- Be 18 years of age or older;
- Be willing and able to provide informed consent electronically;
- Self-report, when answering as a participant, that you have been diagnosed with HD by a doctor, or have undergone genetic testing and been found to carry the gene mutation responsible for HD but have not been clinically diagnosed with HD (prodromal HD);
- Have the ability to answer online questions or direct someone else to enter answers for them;
- Have the ability to ambulate independently and take care of some of your personal needs;
- Have the ability to read and understand English;
- Be willing to create a unique identifier based on personal demographic information;
- Reside in the United States or its territories. Surveys can only be completed in the US. If you move outside of the US, you will no longer be able to participate;
- Own or have access to an electronic device and secure internet connectivity
Exclusion criteria
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Huntington Study Group — Rochester
Identifiers
NCT: NCT06475898 · LEAD-HD